Lokal İleri veya Vücutta Yayılmış TRK Füzyon Kanseri Olan Hastalarda VITRAKVI İlacının Rutin Kullanım Sırasındaki Güvenliği ve Etkinliği Hakkında Daha Fazla Bilgi Edinme Çalışması

Sade dilde özet

Bu çalışma, NTRK gen füzyonu taşıyan, lokal ileri veya vücutta yayılmış TRK füzyon kanseri (TRK fusion cancer) olan hastalarda larotrectinib (Vitrakvi) ilacının rutin kullanım sırasındaki güvenliği ve etkinliği hakkında bilgi toplamayı amaçlamaktadır. Çalışmaya, tümöründe NTRK gen füzyonu saptanmış yetişkin ve çocuk (doğumdan 18 yaşına kadar) hastalar alınmaktadır. Çalışma faz uygulanmayan bir çalışma olarak yürütülmektedir ve halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

N/A

Durum

Katılımcı alıyor

Sponsor

Bayer

Müdahale

larotrectinib(Vitrakvi, BAY2757556)

Başlangıç

03.04.2020

Tahmini bitiş

31.03.2030

Ülkeler

United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Luxembourg, Norway, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom

İlgili genler

Merkezler

• Mesa, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Newport Beach, United States
• Oakland, United States
• Palo Alto, United States
• Santa Monica, United States
• Torrance, United States
• Grand Junction, United States
• New Haven, United States
• Jacksonville, United States
• Miami, United States
• Miami, United States
• Orlando, United States
• Fort Wayne, United States
• Terre Haute, United States
• Wichita, United States
• South Portland, United States
• Baltimore, United States
• Baltimore, United States
• Frederick, United States
• Boston, United States
• Boston, United States
• Farmington Hills, United States
• Lansing, United States
• Las Vegas, United States
• Morristown, United States
• New Brunswick, United States
• Buffalo, United States
• New York, United States
• Staten Island, United States
• Charlotte, United States
• Greenville, United States
• Columbus, United States
• Youngstown, United States
• Philadelphia, United States
• Philadelphia, United States
• Pittsburgh, United States
• Charleston, United States

+36

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Adult and pediatric (from birth to 18-year-old) patients
* Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally. Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is used, this result needs to be accompanied with the results using one of the other methods noted above.
* Life expectancy of at least 3 months based on clinical judgement
* Decision to treat with larotrectinib made by the treating physician prior to study enrollment
* Patients can also be enrolled if the initial visit (larotrectinib start date) occurred within 2 months ±3 days prior to informed consent signed date
* Signed informed consent form
* For patients under legal age, signed assent by the patient (where applicable) and parental/legal guardian signed informed consent is required

Exclusion Criteria:

* Any contraindications as listed in the local approved product information
* Pregnancy
* Participation in an investigational program with interventions outside of routine clinical practice
* Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition
* Patients with NTRK gene amplification or NTRK point mutation